Increasing representation of under-served groups in randomised oncology trials

It is recognised that the diversity of participants enrolling in clinical trials is not always representative of the target population of patients for whom the intervention would be adopted if the trial results are favourable. Appropriate representation of potentially underserved populations is required if we are to ensure that the opportunity for early access to novel treatment options is equitable and results are generalisable to all people affected with the condition. This is particularly critical in oncology, where treatments can be prolonged, follow-up can be lengthy and the impact of both may have different cultural or economic implications for different groups. The PRioRITy study1 identified "what are the best approaches to ensure inclusion and participation of under-represented or vulnerable groups in randomised trials?" and "how can eligibility criteria for trial participants be optimised so that they aid recruitment to randomised trials?" as research priorities. The ICR-CTSU has an established portfolio of randomised controlled phase II and III cancer trials, both of investigational medicinal products and of interventions such as radiotherapy. Several thousand patients are typically enrolled in ICR-CTSU managed trials at over 100 cancer centres and regional hospitals across the UK and internationally each year. This provides an opportunity to explore equality, diversity and inclusion (EDI) characteristics, potential EDI-related barriers to recruitment and a framework for testing interventions for broader representation of underserved populations. ICR-CTSU has reviewed its trial portfolio with respect to inclusion/exclusion criteria and The INCLUDE2 Ethnicity Framework (abstract submitted to International Clinical Trials Methodology Conference for presentation in Q3 2022). The studentship will build on this pilot work with a focus on randomised trials of cancer treatments and extension into "hidden" demographics data.